PREPARE aims to build Europe’s capacity for rapid clinical research responses to severe ID outbreaks with epidemic potential, specifically by initiating large-scale pan-European clinical research studies. PREPARE has the flexibility to respond to “any severe ID outbreak” defined as “any severe infectious outbreak with a pandemic potential or significant risk of major damage to health and socio-‐economics in the EU”.
Details of how PREPARE responds to ID outbreaks can be found here.
QUESTIONS AND ANSWERS
How does PREPARE respond to ID outbreaks that present a threat to Europe?
PREPARE delivers clinical research in one of four modes:
PREPARE is active during inter-epidemic periods (Mode 0) delivering observational and interventional multi-site clinical studies across Europe. These research activities are orientated toward syndromes of acute, community-acquired infectious diseases with epidemic or pandemic potential. You can read more about PREPARE activities in the corresponding sections of this website.
If there is a threat to Europe of a (re-) emerging severe ID outbreak, epidemic or pandemic, PREPARE can be triggered to respond.
An internal assessment will be made as to the most appropriate response for that ID outbreak.
- A mode 1 response is delivered if the ID outbreak presents a limited threat to Europe
- A mode 2 response is delivered if the ID outbreak presents a potential threat to Europe
- A mode 3 response if delivered if the ID outbreak presents an immediate threat to Europe.
How is PREPARE triggered to respond?
PREPARE is triggered when a formal request to respond to a specific threat is sent to PREPARE’s co-ordinator, Herman Goossens.
That request is completed on a form that asks the person making the request to outline their concerns and what response they would like PREPARE to consider. The trigger form can be found here.
Who can trigger PREPARE to respond?
Anyone can submit a ‘trigger’ request to PREPARE to respond; however you must have credible and expert information to support your request.
To date, all triggers have come from expert sources that have information about unusual infectious disease activity inside or outside of Europe.
Can I trigger PREPARE to respond?
If you have credible information about unusual infectious disease activity that you consider poses a threat to Europe, requiring a clinical research response, then you can submit a trigger request.
PREPARE delivers a clinical research response and that this is different from a public health response. In completing the trigger you will be asked to give some examples of the kind of response you would like PREPARE to deliver. This includes suggestions of clinical research questions. If you can’t identify any questions you may still complete the trigger. If you do suggest clinical research questions, please note that PREPARE is not obliged to address them.
What happens once a trigger is received?
As soon as a trigger request is received, the request will be screened to check that the information presented is valid, current and up to date. In response to a valid trigger, an internal PREPARE expert group meets within 24 to 72hrs of the request being received. This group is made up of PREPARE’s Co-ordinator, Deputy Co-ordinator and two additional members from the PREPARE executive board: one with expertise in clinical microbiology and one with expertise in infectious disease. Both additional members also have experience of conducting clinical studies and of infectious diseases outbreaks. Using expert source data and expert opinion, this group will decide whether there is a threat to Europe from the Infectious Disease outbreak stated in the trigger. This group also decides if there is a need for a clinical research response by considering, for example, what is known about effective prevention, diagnostic and treatment options for that outbreak, and if there are outstanding clinical research questions within the remit of PREPARE to respond to. The group will also decide on the PREPARE response mode to be activated.
How long does it take the group to make a decision on the correct outbreak response mode?
This will vary according to the outbreak. PREPARE will be looking to act as efficiently as possible. However often new information emerges quickly during an outbreak and PREPARE must also make sure its decision to act is not premature. The expert decision-making group will be guided by best available evidence in making their decision and will be actively monitoring any outbreak to ensure their decision regarding an Outbreak Research Mode is proportionate.
If PREPARE anticipates escalating to a Mode 2 or Mode 3 response it will need approval of this decision by the General Assembly and our funders, the European Commission. These processes are detailed in our Outbreak Clinical Research Modes Plan.
The outcome and rationale of the response mode decision will be communicated back to the contact on the trigger request and published on the PREPARE website.